Vessel access and closure device

ABSTRACT

A vessel access and closure device places a running suture in the wall of a blood vessel using a rotating helical suture needle that carries the suture along a helical path passing through the vessel wall, then reverses rotation to release a suture anchor attached to the distal end of the suture. A loose helical coil of suture is left behind as the helical suture needle withdraws. The device is withdrawn and replaced with a vessel dilator and an introducer sheath that opens up a larger access opening into the blood vessel and creates a pathway that passes though the helical coil of suture for introducing an interventional device into the blood vessel. After the interventional procedure is completed, the interventional device and the introducer sheath are withdrawn and the running suture is tightened and secured with a suture lock to close the access opening into the vessel.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of International Patent ApplicationNo. PCT/US2010/027321, filed Mar. 15, 2010, which claims priority fromU.S. Provisional application, No. 61/210,018, filed on Mar. 14, 2009,the entire disclosures of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to devices and methods for gainingpercutaneous access to the lumen of a blood vessel and for subsequentlyclosing the access site into the blood vessel. The invention isparticularly advantageous for facilitating percutaneous vessel accessand closure for large diameter interventional devices.

Minimally-invasive, catheter-based interventions have in many waysrevolutionized the treatment of vascular disease. In many interventionalprocedures, an interventional device is introduced to the body throughthe patient's femoral artery or vein (percutaneous approach). Theaverage diameter of the femoral artery in an adult patient isapproximately 12 mm outside diameter and about 10 mm inside diameter.Each year, new interventional procedures become available for treatingnew indications. Some of these new interventional procedures requirelarger, more complex catheters. The larger the catheter orinterventional device that is used, the more challenging it is toeffectively close the opening in the blood vessel at the end of theprocedure in order to avoid bleeding, hematomas and other complications.Vascular closure devices are available to facilitate vessel closureafter procedures using smaller interventional devices, sizes 6-12 French(2-4 mm diameter). Above 12 French, it becomes particularly challengingto close the opening into the blood vessel. To date, no one hasintroduced a vascular closure device that is suitable for providingpercutaneous access and for subsequently closing the access site intothe blood vessel for interventional procedures using catheters in therange of 12-24 French (4-8 mm diameter). For this reason, manyinterventional procedures using larger catheters rely on a vesselcutdown to access the vein or artery. Using a surgical cutdown to accessthe blood vessel undermines the minimally-invasive aspect of theinterventional procedure.

Therefore, what is much needed and has heretofore been unavailable aredevices and methods for facilitating percutaneous access to the lumen ofa blood vessel and for subsequently closing the access site into theblood vessel that are suitable for use with large diameterinterventional devices.

BRIEF SUMMARY OF THE INVENTION

To satisfy this unmet clinical need, the present invention provides avessel access and closure device that places a running suture in thewall of a blood vessel and creates an access site through the wall ofthe blood vessel in the area bounded by the running suture. Optionally,an introducer sheath may be placed through the access site into thevessel lumen. One or more interventional devices may be inserteddirectly through the access site or through the introducer sheath forperforming an interventional procedure within the patient's vascularsystem. Once the interventional procedure has been completed, theinterventional devices and the introducer sheath are withdrawn and therunning suture is tightened to close the access site into the vessel. Asuture lock or a knot may be used to lock the running suture.

The vessel access and closure device utilizes a rotating helical sutureneedle that carries a suture along a helical path through the wall ofthe blood vessel. When the direction of rotation reverses, a sutureanchor attached to a distal end of the suture is released, anchoring thesuture to the vessel wall. A loose helical coil of suture is left behindas the helical suture needle withdraws. The vessel access and closuredevice is withdrawn and replaced with a vessel dilator and an introducersheath that opens up a larger access opening into the blood vessel andcreates a pathway for introduction of interventional device into theblood vessel. Alternatively, the vessel dilator and introducer sheathmay be integrated with the vessel access and closure device.

The vessel access and closure device described herein could also be usedto close other tubular organs (intestine, esophagus, airways, etc.) andalso non tubular organs (abdominal fascia, etc.).

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a vessel access and closure deviceaccording to the present invention shown in a partially deployedposition.

FIG. 2 is an exploded view of the vessel access and closure device ofFIG. 1.

FIG. 3 is cutaway view showing the internal structure of the vesselaccess and closure device of FIG. 1.

FIGS. 4, 5 and 6 show close up views of the distal end of the vesselaccess and closure device, showing how the helical suture needle withthe suture on it emerges from the suturing tip and passes through thewall of the blood vessel.

FIGS. 7-22 illustrate a method of using the vessel access and closuredevice to open a pathway into the lumen of a blood vessel andsubsequently to close the point of entry into the blood vessel.

FIG. 23 is a perspective view and FIG. 24 is a front view illustratinganother embodiment of the vessel access and closure device incorporatingadditional features.

FIG. 25 shows an enlarged view of the helical suture needle with thesuture and the suture anchor.

FIG. 26 shows an enlarged view of another variation of the sutureanchor.

FIGS. 27 and 28 illustrate a helical suture needle with a toggle-shapedsuture anchor.

FIG. 29 shows a suture anchor with a tissue-piercing point configured tofit into the tubular distal end of a helical suture needle.

FIG. 30 shows another suture anchor with a tissue-piercing pointconfigured with a multiplicity of small barbs.

FIGS. 31 and 32 show a distal portion of a tubular helical suture needlewith a suture anchor made of a superelastic or shape memory NiTi alloywire.

FIGS. 33, 34 and 35 show a distal portion of a tubular helical sutureneedle with a suture anchor configured as an expandable cage.

FIGS. 36A-36B illustrate a helical suture needle made from asuperelastic NiTi alloy.

FIGS. 37A-37D illustrate a guiding element with a D-shaped crosssection.

FIG. 38 illustrates a D-shaped guiding element with additional feature.

FIG. 39 shows another embodiment of a guiding element having a backturn.

FIG. 40 shows a spacer mechanism that presses the guiding elementagainst the near wall of the blood vessel.

FIG. 41 shows a cross section of a helical suture needle with a V-shapedgroove for holding a suture.

FIG. 42 shows a cross section of a helical suture needle with a U-shapedgroove for holding a suture.

FIG. 43 shows a cross section of a helical suture needle with arectangular channel for holding a suture.

FIG. 44 illustrates a flat suture that is folded back on itself forstoring additional length of suture.

FIGS. 45, 46 and 47 illustrate how a tubular suture can be prolapsedonto itself to store additional length of suture.

FIGS. 48 and 49 illustrate a telescopically expandable suture.

FIGS. 50 and 51 illustrate an expanding dilator.

FIGS. 52 and 53 illustrate a dilator with an expandable tapered tip.

FIG. 54 illustrates an inflatable balloon with a nonoccluding figureeight or hourglass cross section.

FIG. 55 illustrates an inflatable balloon with a nonoccluding X-shapedcross section.

FIGS. 56 and 57 illustrate an inflatable balloon in a barbellconfiguration.

FIG. 58 illustrates a coil buncher device for deflecting or redirectingthe helical surgical needle.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 is a perspective view of a vessel access and closure device 100according to the present invention shown in a partially deployedposition for placing a running suture in the wall of a blood vessel V.FIG. 2 is an exploded view of the vessel access and closure device 100of FIG. 1. FIG. 3 is cutaway view showing the internal structure of thevessel access and closure device 100 of FIG. 1.

The vessel access and closure device 100 has an elongated shaft portion104 with a proximal end 106 and a distal end 108. A proximal handle 102is connected to the elongated shaft portion 104 at the proximal end 106.The proximal handle 102 has a stationary portion 110 and a rotatingportion 112 located proximal to the stationary portion 110. Preferably,the rotating portion 112 of the proximal handle 102 will have a contour116 and/or texture configured for easy gripping by the operator forapplying torque to rotate the rotating portion 112. Additionally, therotating portion 112 may have a line 118 or other marking to indicatethe rotational position of the rotating portion 112. Preferably, thestationary portion 110 of the proximal handle 102 is configured with awing-shaped raised portion 114, preferably located at a 12 o'clockposition on the closure device 100, that serves as a handle to applytorque to resist rotation of the device 100 when the rotating portion112 is rotated and as a visual and tactile indicator to the operator ofthe device orientation.

As shown in FIG. 2, the elongated shaft portion 104 has a hollow,tubular outer shaft 120 with an inner lumen 122 that, when assembled asin FIG. 3, is fixed at its proximal end 106 to the stationary portion110 of the proximal handle 102. Positioned within the inner lumen 122 ofthe outer shaft 120 is a hollow, tubular inner shaft or torque tube 124with a central lumen 126 that, when assembled, is fixed at its proximalend 128 to the rotating portion 112 of the proximal handle 102.Preferably, the outer shaft 120 and the torque tube 124 are eachconstructed of stainless steel tubing or, alternatively, another metal,such as a titanium or cobalt-chromium alloy, a rigid polymer or areinforced polymer composite. A helical suture needle 132 having amultiplicity of helical turns or coils is connected at its proximal end138 to the distal end 130 of the torque tube 124. The helical sutureneedle 132 has a central passage 134 that is axially aligned with thecentral lumen 126 of the torque tube 124. For ease of manufacture andassembly, the helical suture needle 132 will preferably have an outerdiameter that is approximately the same as the outer diameter of thetorque tube 124. The helical suture needle 132 is configured to carry asuture thread along the helical coil. For this purpose, the helicalsuture needle 132 may be hollow or it may be solid, but with a groove orchannel to carry the suture, as will be discussed in greater detailbelow. Preferably, the helical suture needle 132 is constructed of ametal, such as stainless steel or a titanium, nickel-titanium orcobalt-chromium alloy. The distal end 136 of the helical suture needle132 will typically be sharpened into a tissue-penetrating point, howeverother possible configurations are described below.

A specially contoured suturing tip 140 is attached at the distal end 108of the outer shaft 120 and proximal to it, inside the inner lumen 122 ofthe outer shaft 120, is attached a needle guide 142 with a helicalgroove 144 on its exterior having approximately the same diameter andpitch as the helical suture needle 132. A guidewire lumen 145 extendsthrough the center of the needle guide 142 and aligns with the centrallumen 126 of the torque tube 124. Preferably, a hemostasis valve 127,such as an elastic membrane with a hole or slit through it, is providedat the proximal end of the handle 102 to prevent excessive bleedingthrough the central lumen 126. The hemostasis valve 127 provides asliding seal for insertion of the guidewire 202 and, optionally, for thepositioning member 242, dilator 210 and/or introducer sheath 222described below. The needle guide 142 and the suturing tip 140 do notrotate with respect to the outer shaft 120. The needle guide 142 may beattached to or integral with the suturing tip 140 or it may be attacheddirectly to the outer shaft 120. When assembled, the helical sutureneedle 132 rides in the helical groove 144 of the needle guide 142.Alternatively, the needle guide 142 may be made without the helicalgroove 144.

The stationary portion 110 of the proximal handle 102 is preferably madeof a rigid polymer material, such as polycarbonate, nylon, ABS,polyurethane, etc., and may be molded as one piece or two and assembledonto the proximal end 106 of the outer shaft 120 by insert molding,compression, adhesives, pins, set screws, keys, splines or any othersecure method. In the example shown, the proximal end 106 of the outershaft 120 is inserted into a cylindrical pocket 146 in distal end of thestationary portion 110 of the proximal handle 102 and secured withadhesive. The stationary portion 110 of the proximal handle 102 has acylindrical portion 154 and an annular boss 148 that is just slightlylarger in diameter than the cylindrical portion 154. A ball detent 150or the like is inserted into a transverse hole 155 in the annular boss148, preferably located at a 12 o'clock position.

For ease of manufacture and assembly, the rotating portion 112 of theproximal handle 102 is preferably molded as two pieces 111, 113 andassembled onto the proximal end 128 of the torque tube 124 and thestationary portion 110 of the proximal handle 102 at the same time. Thetwo pieces 111, 113 of the rotating portion 112 may be joined togetherby adhesives, screws, etc. The proximal end 128 of the torque tube 124fits into a central bore 156 at the proximal end of the rotating portion112 of the proximal handle 102 and is secured by an adhesive.Optionally, an annular ridge 158 may be molded at the proximal end ofthe central bore 156 to assure proper axial positioning of the torquetube 124 during assembly. During assembly, the line 118 on the rotatingportion 112 is axially aligned with the distal end 136 of the helicalsuture needle 132.

The rotating portion 112 of the proximal handle 102 has an internalcylindrical portion 160 that is delineated on the proximal end by theproximal wall 162 of the rotating portion 112 of the proximal handle 102and on the distal end by an inwardly projecting annular flange 164. Theinternal cylindrical portion 160 has an inner diameter that is justslightly larger than the outer diameter of the annular boss 148 on thestationary portion 110 of the proximal handle 102. The inwardlyprojecting annular flange 164 has an inner diameter that is justslightly larger than the outer diameter of the cylindrical portion 154of the stationary portion 110 of the proximal handle 102, but slightlysmaller than the annular boss 148. Thus, the rotating portion 112 of theproximal handle 102 is able to rotate and move axially on the stationaryportion 110, but the axial movement in the proximal direction is limitedby the inwardly projecting annular flange 164 and in the distaldirection by the proximal wall 162 of the rotating portion 112.

A longitudinal groove 166 is molded into the internal cylindricalportion 160 of the rotating portion 112 of the proximal handle 102,preferably located at a 12 o'clock position where the two pieces 111,113 of the rotating portion 112 join. The longitudinal groove 166interacts with the ball detent 150 each time it rotates past the 12o'clock position to give an audible and/or tactile indication to theoperator that the rotating portion 112, and hence the distal end 136 ofthe helical suture needle 132 also, is rotating past the 12 o'clockposition.

As the rotating portion 112 of the proximal handle 102 rotates in thedirection of the helix of the helical suture needle 132 (clockwise inthe example shown), the helical suture needle 132 engages the helicalgroove 144 on the needle guide 142, moving the helical suture needle132, the torque tube 124 and the rotating portion 112 distally withrespect to the outer shaft 120 and the stationary portion 110 of theproximal handle 102.

In an alternative configuration, the rotating portion 112 of theproximal handle 102 may be molded as a single piece that is threadedonto the stationary portion 110 of the proximal handle 102. The screwthreads between the rotating portion 112 and the stationary portion 110will preferably have a pitch that is equal to the pitch or coil-to-coildistance of the helical suture needle 132 so that the rotating portion112 will advance and retract synchronously with the helical sutureneedle 132. This configuration controls the axial movement of therotating portion 112 with respect to the stationary portion 110 andobviates the need for the annular boss 148 and the inwardly projectingannular flange 164 described above.

FIGS. 4, 5 and 6 show close up views of the distal end of the vesselaccess and closure device 100, showing how the helical suture needle132, with the suture 170 on it, emerges from the suturing tip 140 andpasses through the wall of the blood vessel V. The suturing tip 140 hasa distal face 172 that is at an angle of approximately 45 degrees fromthe longitudinal axis of the elongated shaft portion 104. In otherembodiments, this angle can be from 15 to 135 degrees. The distal face172 of the suturing tip 140 may be flat or it may have a curvature thatis a section of a cylinder with a radius of curvature approximatelyequal to the radius of the blood vessel V that it is intended to be usedwith. The suturing tip 140 is configured so that it gradually redirectsthe helical suture needle 132 from its orientation inside of the closuredevice 100 where the helical suture needle 132 is concentric with thelongitudinal axis of the elongated shaft portion 104 to an orientationwhere the helical suture needle 132 is concentric with an axis that isat an angle of approximately 45 degrees from the longitudinal axis ofthe elongated shaft portion 104. FIG. 5, which shows a phantom view ofthe suturing tip 140, illustrates how this is accomplished. The interiorof the suturing tip 140 defines a curving helical path that graduallyredirects the helical suture needle 132 over a course of 2-3 turns ofthe helical coil. In FIG. 5, coil 174 is concentric with thelongitudinal axis of the elongated shaft portion 104. Coil 176 has beenskewed approximately 15-30 degrees from coil 174 and coil 178 has beenskewed another approximately 15-30 degrees from coil 176. Coil 180 andthe remainder of the coils distal to it are approximately concentricwith an axis that is at an angle of approximately 45 degrees from thelongitudinal axis of the elongated shaft portion 104. Another way toenvision this geometry is that the transitional coils 174, 176, 178 arebunched up together on the inside of the curve, which causes the helicalsuture needle 132 to change direction by approximately 45 degrees.Another feature of the suturing tip 140 is that coils 174 and 176 areentirely inside of the suturing tip 140, whereas coil 178 is exposedalong approximately one half or a turn so that the distal end 136 of thehelical suture needle 132 can take a first bite of the vessel wall V forplacing the suture 170 as it rotates past this position. Coil 180 andthe remainder of the coils distal to it are entirely exposed foradditional bites of the vessel wall V.

A guidewire lumen 182 passes through the suturing tip 140 making agradual bend of approximately 135 degrees to emerge approximatelyparallel to the distal face 172 of the suturing tip 140. When the device100 is assembled, the proximal end of the guidewire lumen 182 of thesuturing tip 140 aligns with the guidewire lumen 145 of the needle guide142 and the central lumen 126 of the torque tube 124.

Another important feature of the vessel access and closure device 100 isa suture anchor 190 that is connected to the distal end of the suture170. Various forms of the suture anchor 190 are shown in FIGS. 25-35.Initially, the suture anchor 190 is located at or near the distal end136 of the helical suture needle 132. The suture anchor 190 isconfigured so that, as the helical suture needle 132 moves through thevessel wall in the distal direction, the suture anchor 190 movessmoothly forward without catching on the tissue, however, when thedirection of the helical suture needle 132 is reversed, the sutureanchor 190 opens or spreads and anchors the distal end of the suture 170to the vessel wall. The helical suture needle 132 leaves a loose helicalcoil of suture 170 in the vessel wall as it is withdrawn. Release of thesuture 170 from the helical suture needle 132 may be passive or active.

FIGS. 7-22 illustrate a method of using the vessel access and closuredevice 100 to open a pathway into the lumen of a blood vessel V andsubsequently to close the point of entry into the blood vessel V. Thismethod, and variations of it, may be performed with any of theembodiments of the vessel access and closure device 100 describedherein. The method is initiated using the Seldinger technique to accessthe lumen of the blood vessel V, which may be an artery or a vein. Asshown in FIG. 7, an access needle 200 is used to puncture the patient'sskin and create a tract through the tissue and into the lumen of theblood vessel V. Optionally, a skin nick may be made with a scalpelbefore or after inserting the access needle 200 to prevent tearing ofthe patient's skin later in the procedure. Preferably, the needlepuncture is made at an angle of approximately 30 to 45 degrees from thecentral axis of the blood vessel V. Blood flashback through the accessneedle 200 may be used to verify that the distal tip of the accessneedle 200 is in the lumen of the blood vessel V and whether an arteryor vein has been correctly accessed. (For clarity, the patient's skinand the tissue surrounding the blood vessel V have been left out ofthese illustrations.)

Next, a special guidewire 202 is inserted through the access needle 200into the lumen of the blood vessel V, as shown in FIG. 8. The guidewire202 has a bend 206 of approximately 135 degrees between a distal portion204 and a proximal portion 208 that is used to locate the wall of theblood vessel V during subsequent steps of the method. Optionally, theguidewire 202 may have a J-shaped tip to avoid potential injury to theinterior of the blood vessel, as is known in the art. The operator canfeel when the bend 206 in the guidewire 202 has exited the distal tip ofthe access needle 200 and entered the lumen of the blood vessel V, asshown in FIG. 8. At this point the access needle 200 is withdrawn,leaving the guidewire 202 to maintain a pathway through the tissue tractcreated by the access needle 200 and into the lumen of the blood vesselV, as shown in FIG. 9.

Optionally, the tissue tract can be dilated using a series of tapereddilators or using an expandable dilator, such as an inflatable balloon,as is know in the art. Whether this step is necessary, depends in parton how large the tissue tract needs to be and how resistant the tissueis to passage of the shaft portion 104 of the vessel access and closuredevice 100. In an alternative method, a tissue cutdown can be used toaccess the exterior of the blood vessel V before inserting the accessneedle 200.

Next, the proximal portion 208 of the guidewire 202 is inserted into theguidewire lumen 182 in the suturing tip 140 and through the guidewirelumen 145 of the needle guide 142 and the central lumen 126 of thetorque tube 124 to emerge from the proximal handle 102. The shaftportion 104 of the vessel access and closure device 100 is advancedthrough the tissue tract while pulling upward gently on the guidewire202 to position the bend 206 of the guidewire 202 at the wall of theblood vessel V, as shown in FIG. 10. The operator will be able to feelwhen the shaft portion 104 of the device 100 has reached the bloodvessel V and the distal face 172 of the suturing tip 140 is against theexterior of the vessel wall, as shown in FIG. 11. Proper positioning ofthe suturing tip 140 can be verified fluoroscopically or with ultrasoundimaging.

As shown in FIGS. 10, 11 and 12, the apparatus may optionally include anadditional positioning device 240 that helps to assure that the sutureis placed in the near wall of the blood vessel V as intended. Thepositioning device 240 may be a separate device insertable through thevessel access and closure device 100 or it may be integrated into vesselaccess and closure device 100. The positioning device 240 has anelongated tubular guiding element 242 with a guidewire lumen 248 that issized to fit over the guidewire 202. The guiding element 242 has atapered dilating tip 246 at its distal end and a biasing element in theform of an inflatable balloon 244 mounted on one side of the guidingelement 242. An inflation lumen connected to the balloon 244 extendsthrough the guiding element 242 to a proximal hub (not shown) on theproximal end of the guiding element 242. Preferably, the balloon 244 hasa very low deflated profile, as shown in FIG. 10, so that it can fitthrough the lumens 182, 145, 126 in the elongated shaft portion 104 ofthe vessel access and closure device 100. The balloon 244 is preferablylocated at a 6 o'clock position on the guiding element 242. A line orother mark (not shown) at a 12 o'clock position on the proximal end ofthe guiding element 242 allows the operator to properly orient theballoon 244 during insertion. The inflated profile may be cylindrical,as shown in FIG. 11, or it may be spheroidal or other shapes describedherein. The balloon 244 may be made of compliant or noncompliantmaterial. The diameter of the inflated balloon 244 is such that itbiases the guiding element 242 toward the near wall of the blood vesselV, so that the helical suture needle 132 will be properly oriented withrespect to the blood vessel wall when it is advanced, as shown in FIG.12.

Optionally, the positioning device 240 may also include a needle guide241 on the guiding element 242 proximal to the balloon 244. The needleguide 241 has a diameter that is larger than the diameter of the guidingelement 242 and is eccentrically positioned on the guiding element 242,as best seen in FIG. 10. The needle guide 241 may be cylindrical or itmay have an elliptical or D-shaped cross section. The needle guide 241assures that the helical suture needle 132 will be properly aligned withthe wall of the blood vessel V when it is advanced. The eccentricpositioning of the needle guide 241 allows the helical suture needle 132to take at least one, and more preferably two bites, of the blood vesselwall proximal to the puncture site, as shown in FIGS. 11 and 12.

The rotating portion 112 of the proximal handle 102 is rotated clockwiselike a knob while holding the stationary portion 110 to prevent it fromrotating. The torque tube 124 transfers the rotation to the helicalsuture needle 132 which engages the helical groove 144 on the needleguide 142 and advances distally, as shown in FIG. 12. The proximalhandle 102 may include a visual indication of the position of thestationary portion 110 with respect to the rotating portion 112 and/or acounter for recording the number of turns as an indication of theposition of the helical suture needle 132. As can be seen in FIG. 4, thefirst two stitches or bites of the vessel wall made by the helicalsuture needle 132 are proximal to the point where the guidewire 202enters the vessel wall. Approximately 4 to 8 more stitches are madedistal to the point where the guidewire 202 enters the vessel wall.

After a sufficient number of stitches have been placed, the clockwiserotation is stopped, preferably when the distal end 136 of the helicalsuture needle 132 and the suture anchor 190 are at approximately the 12o'clock position outside of the blood vessel V. The rotating portion 112of the proximal handle 102 is then rotated counterclockwise to withdrawthe helical suture needle 132. The suture anchor 190 engages the vesselwall and prevents the suture 170 from backing out. A loose helical coilof suture 170 is left behind as the helical suture needle 132 withdraws,as shown in FIG. 13.

The vessel access and closure device 100 is withdrawn from the tissuetract leaving the helical coil of suture 170 in the vessel wall and theguidewire 202, which maintains a pathway through the tissue tract andthrough the center of the helical coil of suture 170, as shown in FIG.14.

At this point, there are a number of options in the procedure. Aninterventional device may be introduced directly over the guidewire 202,through the tissue tract and into the lumen of the blood vessel V. Thisoption is feasible when the interventional device has a smoothly tapereddistal end that will pass through the vessel wall by gradually dilatingthe puncture site. The diameter of the interventional device wouldpreferably be smaller than the diameter of the helical coil of suture170 so that it could easily pass through the coil into the lumen of theblood vessel V. (Alternatively, a stretchable or extendable suture, asdescribed herein below, would allow an interventional device that isactually larger in diameter than the helical coil of suture 170 to passthrough.) An example of a device suitable for this variation of themethod would be a large dilatation balloon, such as a valvuloplastyballoon. Another option is to insert an introducer sheath with a coaxialdilator over the guidewire 202, through the tissue tract and into thelumen of the blood vessel V. An introducer sheath allows interventionaldevices that might have a more a complex geometry with projections thatmight otherwise catch or snag on the suture 170 or the vessel wall to beeasily passed through the puncture site into the lumen of the bloodvessel V. An example of a device suitable for this variation of themethod would be a stent graft for repair of abdominal aortic aneurysms.For interventional devices requiring a large diameter introducer sheathit may not be sufficient to simply dilate the puncture through thevessel wall because the vessel wall might tear rather than graduallydilate as intended. An example of a device that might require a largediameter introducer sheath might be a catheter for implanting a stentedpercutaneous aortic valve replacement. For this situation, the presentinvention includes, as an option, a cutting or scoring dilator 210 thatis illustrated in FIGS. 15 and 16.

The cutting or scoring dilator 210 has a tapered dilating tip 212 on thedistal end of a cylindrical body. A cutting or scoring element 214located on one side of the tapered portion 212. The cutting or scoringelement 214 is oriented longitudinally on the dilator 210 and ispreferably located at a 12 o'clock position. A line or other mark on theproximal end of the dilator 210 indicates the orientation of the cuttingor scoring element 214 to the operator. The cutting or scoring element214 may be configured as a sharp cutting blade that actually cuts thevessel wall along a longitudinal line or it may be a wire, a wedge or araised ridge that causes a stress riser in the vessel wall so that itpreferentially splits or tears along a longitudinal line as the puncturesite is dilated. Preferably, the cutting or scoring element 214 does notextend to the full outer diameter of the dilator 210, so that last bitof the insertion site through the vessel wall is dilated rather than cutor split. This provides better hemostasis at the insertion site and, inthe case of a cutting or scoring element 214 configured as a sharpcutting blade, prevents the blade from cutting the helical coil ofsuture 170 that is in place. Alternatively or in addition, the cuttingor scoring element 214 may have an electrocautery or electrocoagulationcapability. Optionally, the cutting or scoring dilator 210 may also havea flexible lead section 216 that is smaller in diameter extendingdistally from the tapered dilating tip 212. The flexible lead section216 improves the ability of the cutting or scoring dilator 210 to followthe guidewire 202 around the bend 206 into the lumen of the blood vesselV. A guidewire lumen 220 extends through the flexible lead section 216and the body 218 of the cutting or scoring dilator 210. Alternatively,the cutting or scoring element 214 may be located on this flexible leadsection 216. Preferably, a thin-walled introducer sheath 222 ispositioned coaxially around the body 218 of the cutting or scoringdilator 210. Alternatively, a thin-walled introducer sheath 222 can becollapsed flat and introduced beside the body 218 of the cutting orscoring dilator 210. The introducer sheath 222 would be opened up to itsfull diameter after the dilator 210 has been withdrawn.

FIG. 15 shows the cutting or scoring dilator 210 following the guidewire202 through the tissue tract. The distal tip of the flexible leadsection 216 is positioned to enter the puncture site through the vesselwall. FIG. 16 shows the cutting or scoring dilator 210 with the taperedportion 212 inside the lumen of the blood vessel V. By a combination ofcutting, tearing or splitting and dilating, the cutting or scoringdilator 210 has enlarged the puncture site to an insertion site largeenough for the introducer sheath 222. The cutting or scoring dilator 210also passes through the helical coil of suture 170 and may optionallydilate it to a larger diameter.

FIG. 17 shows the cutting or scoring dilator 210 being withdrawn,leaving the introducer sheath 222 in place through the tissue tract andinto the lumen of the blood vessel V. The introducer sheath 222 alsopasses through the center of the helical coil of suture 170, as shown inFIG. 18.

Once the introducer sheath 222 is in place, a variety of diagnostic,therapeutic and/or interventional devices 230 can be inserted throughthe introducer sheath 222, as shown in FIG. 19. The guidewire 202 may beused to introduce the interventional device 230 or it may be withdrawnand discarded if it is of no further use in the procedure. Theinterventional procedure may be performed anywhere in the vasculaturethat is accessible from the insertion site.

Once the interventional procedure has been completed, the interventionaldevice 230 and then the introducer sheath 222 are withdrawn, leavingonly the helical coil of suture 170 in place, as shown in FIG. 20. Thesuture 170 is pulled until it tightens from a loose coil into a runningsuture that closes the insertion site, as shown in FIG. 21. A knot or asuture lock 232 is placed on the suture 170 and slid down the suture 170to lock the running suture in place, as shown in FIG. 22. A tube or asurgical knot pusher can be used to push the knot or suture lock 232down through the tissue tract and along the suture 170. Optionally, thesuture 170 may be cut off proximal to the suture lock 232. Optionally,an adhesive or sealant may be applied to the suture 170 and theinsertion site. If necessary, additional sutures, adhesives or collagenplugs may be used to close and/or promote healing of the tissue tract.

A radiopaque contrast agent can be injected for confirmation ofpositioning and mapping of the blood vessel and its sidebranches byfluoroscopy at different points during the procedure. For example, theaccess needle 200, the guiding element 242, the vessel access andclosure device 100, the dilator 210 and the introducer sheath 222 eachhave a lumen that can be used for radiopaque dye injections. Inaddition, each of the components may have radiopaque markers and/or bemade of a radiopaque material to facilitate fluoroscopic imaging.

The following are given as nonlimiting examples of the dimensions andmaterials for some of the components of the vessel access and closuredevice 100. The helical suture needle 132 will preferably have a needlediameter in the range of approximately 0.015-0.050 inches, a helixdiameter in the range of approximately 0.100-0.500 inches, and a lengthin the range of approximately 0.25-1.5 inches. The pitch or coil-to-coildistance of the helical suture needle 132 will preferably be in therange of approximately 0.030-0.125 inches and the number of coils orturns will be approximately 6-20. The elongated shaft portion 104 willpreferably have an outside diameter in the range of approximately0.100-0.375 inches and a length in the range of approximately 3-18inches. The suture 170 will preferably be size 5-0 or larger and may bemonofilament, braided, profiled shape (mono or braided), coated, dippedand/or lubricated and may be made from nylon, ultra high molecularweight polyethylene, silk, gut, expanded PTFE, absorbable polymers, etc.The guidewire will preferably have a diameter in the range ofapproximately 0.014-0.045 inches, more preferably 0.035-0.038 inches,though other sizes may also be used. The cutting or scoring dilator 210will preferably have an outside diameter in the range of approximately6-24 French (2-8 mm) and the introducer sheath 222 will preferably havean inside diameter in the range of approximately 6-24 French that ismatched to the outside diameter of the cutting or scoring dilator 210.

FIG. 23 is a perspective view and FIG. 24 is a front view illustratinganother embodiment of the vessel access and closure device 100incorporating some additional features. The vessel access and closuredevice 100 has an elongated shaft portion 104 connected to a proximalhandle 102. In this embodiment, the rotating portion 112 is located onthe distal end of the proximal handle 102, distal to the stationaryportion 110. The rotating portion 112 is connected to the torquetransmitting member 124 by a planetary gear mechanism or the like (notshown). A positioning device 240, similar to the one described above, isincorporated into the device 100. A sliding control button 248 on theproximal handle 102 controls the advancement and retraction of aretractable cutter that cuts a larger access opening at the puncturesite. Optionally, the positioning device 240 may also be maderetractable. Another sliding control button could be located on theproximal handle 102 to control the advancement and retraction of thepositioning device 240. An inflation tube with a stopcock 249 connectsto a pressure source, such as a syringe (not shown), for inflating anddeflating the balloon 244. Because the positioning device 240 isconnected to the proximal handle 102, the correct orientation of theballoon 244 in the blood vessel is assured.

In other embodiments of the vessel access and closure device 100, amotor or other mechanism may be provided to drive the rotation of thehelical suture needle 132. The motor may be located in the proximal ordistal end of the device 100. Other manually operated mechanisms mayalso be used to drive the rotation of the helical suture needle 132. Forexample, a handle or trigger may be connected to the torque transmittingmember 124 by a rack-and-pinion or other gear mechanism that turnslinear motion to rotary. The handle or trigger would be squeezed torotate the helical suture needle 132. A lever or knob may be provided toreverse the direction of rotation.

FIG. 25 shows an enlarged view of the helical suture needle 132 with thesuture 170 and the suture anchor 190. The suture anchor 190 is attachedto the distal end of the suture 170, for example by adhesive,overmolding, crimping, swaging, tying or forming integrally with it. Thesuture anchor 190 is releasably attached to the helical suture needle132 by a ring or collar 192 that fits around the suture needle 132 andrests against a shelf or ledge 133 on the suture needle 132. The sutureanchor 190 has at least one, and preferably two or more, resilient barbs191 that are angled backward so the suture anchor 190 will move easilythrough the tissue in a forward direction along with the helical sutureneedle 132. When the direction of the helical suture needle 132 isreversed, the barbs 191 will spread to anchor the suture anchor 190 andthe suture 170 to the blood vessel wall. The reverse motion will alsodislodge the collar 192 of the suture anchor 190 from the shelf or ledge133, thus releasing the suture anchor 190 from the suture needle 132.

FIG. 26 shows an enlarged view of another variation of the suture anchor190. The suture anchor 190 is attached to the distal end of the suture170, for example by adhesive, overmolding, crimping, swaging, tying orforming integrally with it. As above, the suture anchor 190 has a pairof resilient barbs 191 that are angled backward. In this variation, thesuture anchor 190 is releasably attached to the helical suture needle132 by inserting one of the barbs 191 into an obliquely drilled hole 135in the suture needle 132. The backward-angled resilient barb 191 allowsthe suture anchor 190 to move easily through the tissue in a forwarddirection along with the helical suture needle 132. When the directionof the helical suture needle 132 is reversed, the barbs 191 will spreadto anchor the suture anchor 190 and the suture 170 to the blood vesselwall. The reverse motion will also dislodge the suture anchor 190 fromthe hole 135, thus releasing the suture anchor 190 from the sutureneedle 132.

As mentioned previously, the helical suture needle 132 may be tubular,formed for example from stainless steel or NiTi alloy hypodermic needletubing. The suture 170 and the suture anchor 190 may fit inside of thehelical suture needle 132, as shown in FIG. 27. The suture anchor 190may have barbs, as described above, or it may be configured as a simpletoggle 193 attached near its middle to the suture 170. After the helicalsuture needle 132 has advanced through the blood vessel wall, the toggle193 is ejected from the helical suture needle 132, preferably on theexterior of the blood vessel, to anchor the suture 170, as shown in FIG.28.

FIG. 29 shows a suture anchor 190 with a tissue-piercing point 194 thatis configured to fit into the tubular distal end of a helical sutureneedle 132. The suture anchor 190 may have barbs, as described above, orit may be attached to the suture 170 near its middle to act as a togglefastener.

FIG. 30 shows another suture anchor 190 with a tissue-piercing point 194that is configured with a multiplicity of small barbs 195 to anchor thesuture 170 to the blood vessel wall or surrounding tissue.

The suture anchors 190 shown in FIGS. 29 and 30 can also be adapted fitonto the distal end of a solid helical suture needle 132.

FIGS. 31 and 32 show a distal portion of a tubular helical suture needle132 with a suture anchor 190 made of a superelastic or shape memory NiTialloy wire 196. A distal portion of the wire 196 is preformed by heattreating into a curvature, for example a spiral coil, that will act as asuture anchor 190, as shown in FIG. 32. The curvature in the wire 196can be straightened out by drawing it into tubular helical suture needle132, as shown in FIG. 31. After the helical suture needle 132 hasadvanced through the blood vessel wall, the wire 196 is advanced out ofthe helical suture needle 132, preferably on the exterior of the bloodvessel, and the curvature reforms to anchor the suture 170, as shown inFIG. 32.

FIGS. 33, 34 and 35 show a distal portion of a tubular helical sutureneedle 132 with a suture anchor 190 configured as an expandable cage197, preferably of superelastic or shape memory NiTi alloy wire. Theexpandable cage 197 can be compressed to fit into the tubular helicalsuture needle 132, as shown in FIG. 33. After the helical suture needle132 has advanced through the blood vessel wall, the expandable cage 197is ejected from the helical suture needle 132, preferably on theexterior of the blood vessel, and the expandable cage 197 expands toanchor the suture 170, as shown in FIG. 34. FIG. 35 shows the expandablecage 197 of the suture anchor 190 anchoring the suture 170 to the wallof the blood vessel V.

The following describes additional features of the invention that may becombined with the embodiments of the vessel access and closure device100 described above.

Optionally, excitation of the helical suture needle 132 with subsonic,sonic or ultrasonic vibration may be used to facilitate passing theneedle through the wall of the blood vessel. This feature may beespecially advantageous when the walls of the blood vessel are heavilycalcified. Another way to facilitate passing the needle through the wallof the blood vessel would be to wind up and release stored spring energyin the helical suture needle 132 to move the distal tip 136 of theneedle forward quickly to pierce the vessel wall.

Similarly, excitation of the cutting or scoring dilator 210 and/or thecutting or scoring element 214 with subsonic, sonic or ultrasonicvibration may be used to facilitate cutting and dilating the accessopening through the wall of the blood vessel.

FIGS. 36A-36B illustrate a helical suture needle 132 made from asuperelastic NiTi alloy. The helical suture needle 132 can bestraightened out for insertion though a small diameter lumen 201 in anaccess needle 200 or other device, as shown in FIG. 36A. Once thesuperelastic helical suture needle 132 is out of the lumen 201, itresumes its helical configuration, as shown in FIG. 36B.

FIGS. 37A-37D illustrate another embodiment of a guiding element 250with a D-shaped cross section. The guiding element 250 with a D-shapedcross section can be a separate device or it can be incorporated intoeither the guidewire 202 and/or the positioning device 240 describedabove. Optionally, the D-shaped guiding element 250 may have a guidewirelumen so that it can be introduced over the guidewire 202. With theD-shaped guiding element 250 pressed against the inside of the bloodvessel wall, as shown in FIG. 37B, the helical suture needle 132 will beconstrained to pass through the blood vessel wall at the 10 o'clock and2 o'clock positions. FIG. 37C shows how, with a change in the geometryof the D-shaped guiding element 250, the helical suture needle 132 canbe made to pass through the blood vessel wall at the 11 o'clock and 1o'clock positions, or any desired positions. FIG. 37D is a perspectiveview of the D-shaped guiding element 250 pressed against the inside ofthe blood vessel V with the helical suture needle 132 rotating around itto place a running suture in the blood vessel wall.

As shown in FIG. 38, the D-shaped guiding element 250 may also beconfigured with a longitudinal groove 251 that interacts with a bump 137on the helical suture needle 132 to make click that provides a tactileindication to the operator every time the helical suture needle 132makes a revolution.

FIG. 39 shows another embodiment of a guiding element 252 with a backturn 254. The guiding element 252 may have a round, elliptical orD-shaped cross section, as described above. The back turn 254 guides thehelical suture needle 132 so that it will place one or more stitches inthe vessel wall proximal to the puncture site.

FIG. 40 shows a spacer mechanism 256 that assures that the guidingelement 258 will be pressed against the near wall of the blood vessel V.The spacer mechanism 256 has a second arm 260 that presses against thefar wall of the blood vessel V, forcing the guiding element 258 againstthe near wall of the blood vessel V. The spreading force between thesecond arm 260 and the guiding element 258 can be from spring action,for example the second arm 260 can be made of a spring material (e.g.stainless steel or a NiTi alloy). Alternatively, the spreading force canbe applied from the proximal ends of the second arm 260 and the guidingelement 258, manually, with a spring or with an inflatable member.

In one option, the suture 170 will be carried on the exterior of thehelical suture needle 132 with a channel or groove 139 to carry thesuture 170. FIG. 41 shows one alternative for the cross section of thehelical suture needle 132. The suture needle 132 is generally round witha V-shaped groove 139 for holding a round suture 170. FIG. 42 showsanother alternative for the cross section of the helical suture needle132. The suture needle 132 is generally round with a U-shaped groove 139for holding a round suture 170. FIG. 43 shows another alternative forthe cross section of the helical suture needle 132. The suture needle132 is generally round with a rectangular channel 139 for holding around or flat suture 170. The channel or groove 139 may be oriented inany direction on the suture needle 132 with respect to the axis of thehelix.

It may be advantageous to have additional length of suture 170 carriedon the helical suture needle 132 so that the helical coil of suture 170placed in the vessel wall can open up to a larger diameter toaccommodate a large diameter introducer sheath and/or interventionaldevice. FIGS. 43 and 44 illustrate one option for storing additionallength of suture 170 on the helical suture needle 132. As shown in FIG.44, a flat suture 170 can be folded back on itself at regular andperiodic intervals along the suture 170. Optionally, the suture 170 maybe tacked with an adhesive 171 to keep it in the folded configurationduring insertion of the helical suture needle 132. FIG. 43 shows how theflat suture 170 can lay stacked in a rectangular channel 139 on thehelical suture needle 132. An amount of suture 170 up to three times thelength of the helical suture needle 132 can be stored in the channel139. After the suture 170 has been placed in the vessel wall, thehelical coil of suture 170 can be enlarged using a tapered dilator orinflatable balloon.

FIGS. 45, 46 and 47 show how a tubular suture 170 can be prolapsed ontoitself to store additional length of suture 170 on the helical sutureneedle 132 analogously to the folded flat suture described above. Thisoption may be particularly applicable to tubular braided sutures. FIG.45 is a perspective view and FIG. 46 is a longitudinal cross section ofthe tubular suture 170 in a prolapsed position. FIG. 47 shows thetubular suture 170 drawn out to its full length. Alternatively, tubularbraided sutures can be compressed axially without prolapsing. Thediameter of a tubular braid increases as its length decreases by axialcompression.

FIGS. 48 and 49 show a telescopically expandable suture 270 that has atubular portion 272 surrounding a small diameter portion 274. FIG. 48shows the telescopically expandable suture 270 in a retracted position.FIG. 49 shows the telescopically expandable suture 270 in an extendedposition. A knot or bead 271 on the small diameter portion 274 stops ata reduced diameter area 273 on the end of the tubular portion 272 tolimit the telescopic elongation of the suture 270. Optionally, thetelescopically expandable suture 270 may have several repeating units oftubular portions 272 surrounding small diameter portions 274.

Another option would be to make the suture 170, 270 from a material thatcan be elastically or plastically elongated. The suture 170, 270 couldthen be stretched to enlarge the helical coil of suture after it hasbeen stitched in place through the blood vessel wall.

Another option would be to provide additional suture length by storingthe suture 170 in a helically coiled or zigzag pattern on the interioror the exterior of the helical suture needle 132.

FIGS. 50 and 51 show an expanding dilator 280 that may be used with thevessel access and closure device 100. The expanding dilator 280 has atapered distal end 281 and a dilator body 282 with a small-diameterprofile that facilitates its entry through the blood vessel wall andinto the helical coil of suture 170, as shown in FIG. 50. After theexpanding dilator 280 is in place, the dilator body 282 can be expanded,for example by inflation with a fluid, to widen the puncture site in thevessel wall and/or to expand the helical coil of suture 170, as shown inFIG. 51. The tapered distal end 281 and/or the dilator body 282 mayoptionally include a cutting or scoring element, as described above.

Another option for the vessel access and closure device 100 is a dilator290 with an expandable tapered tip 291. The expandable tapered tip 291is attached to a cylindrical dilator body 292 and has a plurality ofslits 293 that divide the tapered tip 291 into an equal number ofsectors 294. In the example shown, the expandable tapered tip 291 hasfour slits 293 that divide the tapered tip 291 into four sectors 294. Ina closed position, the expandable tapered tip 291 is approximatelyconical, as shown in FIG. 52. Optionally, the expandable tapered tip 291may have a cutting or scoring element 214 located on one of the sectors294, preferably located at a 12 o'clock position. The expandable taperedtip 291 has an open position where the sectors 294 spread out to thesame diameter as the cylindrical dilator body 292 or even larger ifdesired, as shown in FIG. 53. The expandable tip dilator 290 can be usedas a normal tapered dilator or the expanding action of the tip 291 canoptionally be used to dilate the puncture site in the blood vessel walland/or to dilate the helical coil of suture 170 to a larger diameter.Once the dilator 290 is in place in the lumen of the blood vessel, theexpandable tapered tip 291 can be opened up so that the cylindricaldilator body 292 can be used as an introducer sheath. A pull wire 295 orother mechanism in the dilator 290 may be used to expand the tapered tip291. Examples of other mechanisms that could be used to open theexpandable tapered tip 291 include internal pressure created byinsertion of an interventional device or catheter, inflation of aballoon inserted through or integrated into the dilator 290, a smallmotor, push wires, drive shaft, magnetic force, hydraulic force, electroactive polymers, a shape memory NiTi alloy, etc. Optionally, the cuttingor scoring element 214 may be retractable to avoid the risk of cuttingthe suture 170 when the expandable tapered tip 291 is in the openposition. Another option would be to configure the vessel dilator with aremovable tapered tip that can be withdrawn once the dilator is in thelumen of the blood vessel, allowing the cylindrical dilator body to beused as an introducer sheath.

Another option is a vessel dilator with a screw-shaped tapered tip thatcan be rotated to gradually and controllably dilate the puncture sitethrough the vessel wall.

Optionally, the inflatable balloon 244 that serves as a biasing elementfor the guiding element 242 described above may be configured with anoncircular cross section in order to avoid occluding blood flow throughthe vessel lumen to the extremities or other organs downstream. FIG. 54illustrates an inflatable balloon 244 with a nonoccluding figure eightor hourglass cross section. FIG. 55 illustrates an inflatable balloon244 with a nonoccluding X-shaped cross section.

FIGS. 56 and 57 show another optional configuration for an inflatableballoon 244 for use as a biasing element for the guiding element 242.The inflatable balloon 244 is in a barbell configuration, either with apair of inflatable portions or one single barbell-shaped balloon. Whenthe balloon 244 is inflated, the guiding element 242 is positionedagainst the near wall of the blood vessel.

As mentioned above, it is most desirable to place the suture anchor 190on the exterior of the blood vessel wall in order to avoid the sutureanchor 190 from becoming a nidus for thrombus formation or othercomplications. In addition to the position indicating mechanismsdescribed above, it may be desirable to provide for sensing the positionof the needle tip 136 and/or the suture anchor 190. One method ofsensing the position of the needle tip 136 is with conduction. If all ofthe helical suture needle 132 except for the distal tip 136 is coveredwith an insulative coating, a conductivity or impedance sensor incontact with the blood in the vessel lumen will be able to determinewhen the needle tip 136 is inside or outside of the vessel lumen.Another method would be to place a magnetic element on the distal tip136 of the helical suture needle 132 and to use a magnetic sensor orimaging device to detect the position and the orientation of themagnetic poles.

FIG. 58 shows an alternative method for redirecting the helical surgicalneedle 132. A coil buncher device 300 extends through the elongatedshaft portion 104 of the vessel access and closure device 100 and a loop302 on the distal end of the coil buncher device 300 bunches up thecoils of the helical surgical needle 132 on one side, deflecting orredirecting the helical surgical needle 132. Optionally, the coilbuncher device 300 can be made adjustable so that the angle ofdeflection of the helical surgical needle 132 can be varied. The coilbuncher device 300 can also be rotated within the vessel access andclosure device 100 to change the direction of the helical surgicalneedle 132 from longitudinal to oblique, to perpendicular to thelongitudinal axis of the blood vessel.

Although a longitudinal opening and suture line are thought to bepreferred for vessel access and closure at this time, the vessel accessand closure device of the present invention can also be adapted tocreate and subsequently close an opening at any angle on the vesselwall. For example, the opening and the suture line could be transverseor diagonal, for example at a 45 degree angle to the longitudinal axisof the blood vessel. Optionally, a helically-shaped guiding element thatfollows the inner surface of the blood vessel wall could be used toguide the helical suture needle 132 along a diagonal path.

The vessel access and closure device described herein could also be usedto close other tubular organs (intestine, esophagus, airways, etc.) andalso non tubular organs (abdominal fascia, etc.)

While the present invention has been described herein with respect tothe exemplary embodiments and the best mode for practicing theinvention, it will be apparent to one of ordinary skill in the art thatmany modifications, improvements, combinations and subcombinations ofthe various features and embodiments, adaptations and variations can bemade to the invention without departing from the spirit and scopethereof.

What is claimed is:
 1. A method, comprising: positioning a distal end ofa blood vessel access and closure device against a wall of a bloodvessel in a patient; advancing a distal end of a helical suture needlefrom the blood vessel access and closure device along a helical paththat passes through the wall of the blood vessel, the suture having adistal end releasably attached near the distal end of the helical sutureneedle; retracting the distal end of the helical suture needle into theblood vessel access and closure device along the helical path, leavingthe suture in a helical suture coil that passes into the wall of theblood vessel; creating an access opening through the wall of the bloodvessel within an area of the wall bounded by the helical suture coil;and tightening the helical suture coil to close the access opening inthe wall of the blood vessel.
 2. The method of claim 1, furthercomprising: introducing an interventional device through the accessopening into a lumen of the blood vessel; performing an interventionalprocedure with the interventional device; and withdrawing theinterventional device from the access opening prior to closing theaccess opening in the wall of the blood vessel.
 3. The method of claim1, wherein the step of leaving the helical suture coil in the wall ofthe blood vessel further comprises: redirecting the helical sutureneedle from an orientation aligned with a longitudinal axis of the bloodvessel access and closure device to an orientation aligned with a secondaxis that is at an angle with respect to the longitudinal axis of theblood vessel access and closure device.
 4. The method of claim 1,wherein the second axis is approximately parallel to a longitudinal axisof the blood vessel.
 5. The method of claim 1, wherein the step ofcreating an access opening through the wall of the blood vessel withinthe helical suture coil comprises: passing a vessel dilator through thehelical coil of suture and dilating the access opening through the wallof the blood vessel with a tapered tip of the vessel dilator.
 6. Themethod of claim 1, wherein the step of creating an access openingthrough the wall of the blood vessel within the helical suture coilcomprises: passing a vessel dilator having a tapered tip with a cuttingelement positioned on the tapered tip through the helical coil of sutureand opening the access opening through the wall of the blood vessel withthe tapered tip and the cutting element of the vessel dilator.
 7. Themethod of claim 6, wherein the opening through the wall of the bloodvessel is oriented longitudinally with respect to the blood vessel. 8.The method of claim 1, wherein the step of creating an access openingthrough the wall of the blood vessel within the helical suture coilcomprises: passing a vessel dilator having a tapered tip with a scoringelement positioned on the tapered tip through the helical coil of sutureand opening the access opening through the wall of the blood vessel withthe tapered tip and the scoring element of the vessel dilator.
 9. Themethod of claim 8, wherein the opening through the wall of the bloodvessel is oriented longitudinally with respect to the blood vessel. 10.The method of claim 1, further comprising: introducing at least onedevice through the access opening into a lumen of the blood vessel bypassing the at least one device through the helical coil of suture. 11.The method of claim 10, further comprising: performing an interventionalprocedure on the patient with the at least one device.
 12. The method ofclaim 1, further comprising: percutaneously accessing a lumen of theblood vessel with an access needle; passing a guidewire through aguidewire lumen in the access needle into the lumen of the blood vessel;and withdrawing the access needle, leaving the guidewire to maintain apathway into the lumen of the blood vessel.
 13. The method of claim 12,wherein the guidewire has a distal portion and a proximal portion with abend between the distal portion and the proximal portion, and whereinthe step of positioning a distal end of a blood vessel access andclosure device against a wall of a blood vessel comprises: placingtension on the guidewire while advancing the distal end of the bloodvessel access and closure device along the guidewire to affirmativelyposition the distal end of the blood vessel access and closure deviceagainst the wall of the blood vessel.
 14. The method of claim 1, whereinthe step of positioning a distal end of a blood vessel access andclosure device against a wall of a blood vessel comprises: inserting adistal end of an elongated guiding member through a puncture site in thewall of the blood vessel into a lumen of the blood vessel; expanding abiasing member mounted near the distal end of the elongated guidingmember to bias the elongated guiding member against the wall of theblood vessel; and advancing the distal end of a blood vessel access andclosure device along the elongated guiding member to contact the wall ofthe blood vessel.
 15. The method of claim 14, wherein the step ofexpanding a biasing member mounted near the distal end of the elongatedguiding member comprises: inflating an inflatable balloon attached tothe elongated guiding member to bias the elongated guiding memberagainst the wall of the blood vessel.
 16. The method of claim 14,wherein the step of expanding a biasing member mounted near the distalend of the elongated guiding member comprises: spreading a spacing armapart from the elongated guiding member to bias the elongated guidingmember against the wall of the blood vessel.
 17. The method of claim 1,further comprising: inserting a distal end of an elongated guidingmember through a puncture site in the wall of the blood vessel into thelumen of the blood vessel; positioning a portion of the elongatedguiding member against an interior surface of the blood vessel wall; androtating the helical suture needle around the elongated guiding member.18. The method of claim 17, wherein the elongated guiding member has aD-shaped cross section and the method comprises positioning a flatsurface of the D-shaped elongated guiding member against an interiorsurface of the blood vessel wall.
 19. The method of claim 1, furthercomprising: making a needle puncture through the wall of the bloodvessel; placing at least one stitch of the helical suture coil in thewall of the blood vessel proximal to the needle puncture; and placing atleast one stitch of the helical suture coil in the wall of the bloodvessel distal to the needle puncture.
 20. The method of claim 1, furthercomprising: exciting the helical suture needle with vibrational energywhile advancing the distal end of the helical suture needle through thewall of the blood vessel.
 21. The method of claim 1, wherein the sutureis extendable.
 22. The method of claim 1, wherein the suture isstretchable.
 23. The method of claim 1, wherein additional length of thesuture is placed along the helical path through the wall of the bloodvessel.
 24. The method of claim 1, further comprising: securing thetightened helical suture coil with a suture lock.